Diazyme Laboratories, Inc.

Diazyme Laboratories, Inc. — FDA 510(k) Submissions

Diazyme Laboratories, Inc. has submitted 9 FDA 510(k) premarket notifications since 2018, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Kappa, Antigen, Antiserum, Control, Lipoprotein, Low-density, Antigen, Antiserum, Control, Assay, 1,5-anhydroglucitol (15ag), Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2, System, Test, Human Chorionic Gonadotropin . Use the specialty filter in the sidebar to narrow results.